台北市內湖區2年以上專科待遇面議
我們正在尋找一位敬業且經驗豐富的專業人士,擔任產品法規檢驗專家(Product Regulatory and Quality Assurance Specialist)。此職位對於確保所有產品相關文件與法規要求皆有嚴謹維護,並確保產品符合國內外標準至關重要。
維護產品資訊檔案(PIF)與批次紀錄:
- 確保所有產品資訊檔案與批次紀錄完整、正確、並符合法規要求。
- 定期審核並更新產品相關文件,以反映配方、製程與法規變更。
- 依據台灣新版化妝品法規辦理產品登錄:
- 主導並管理依照台灣新化妝品法規的產品登錄流程。
- 與主管機關聯繫,確保新產品登錄可於時限內順利申報與核准。
驗證產品配方:
- 持有可進行配方驗證的合法證照,並確保所有配方符合安全與法規標準。
- 與研發與產品開發團隊合作,確保新配方在安全性與功效方面皆符合規範。
ISO 認證資格取得:
- 提供 ISO 規範方面的專業指導,協助生產流程達標。
- 協助我們製造場所通過 ISO 認證的準備與申請。
- 透過定期稽核與流程改善,確保持續符合 ISO 要求。
- 擔任台灣 FDA 有關產品合規與安全查詢的主要聯絡人。
- 與產品團隊合作,提供產品安全、法規合規等技術建議。
掌握法規與產業趨勢:
- 持續追蹤台灣與國際化妝品法規、產業趨勢與變動。
- 提供公司建議,預測法規變化可能帶來的影響與應對策略。
資格條件:
- 具藥學、化學、化妝品科學等相關科系學士學位。
- 持有可進行產品配方驗證的合法證照(依台灣法規要求)。
- 熟悉台灣化妝品相關法規知識。
- 有產品登錄、PIF 維護、與 ISO 實務經驗者尤佳。
- 良好溝通能力,能有效與政府機關、內部團隊及外部合作單位協作。
- 細心、具組織力,能同時處理多項任務。
- 具備英文溝通能力者佳(非必要條件)。
- 若有微生物檢驗證書佳(非必要條件)。
Responsibilities:
Maintain Product PIF Files and Batch Records:
-Ensure that all Product Information Files (PIFs) and batch records are accurate, up-to-date, and in compliance with regulatory requirements.
-Regularly review and update product documentation as necessary to reflect formulation, manufacturing, and compliance changes.
-Product Registration under New Cosmetics Regulations:
Oversee and manage the product registration process under Taiwan's new cosmetics regulations. Liaise with regulatory bodies to ensure timely submission and approval of new product registrations.
Validate Product Formulas:
-Hold a valid license to validate product formulas and ensure they comply with safety and regulatory standards.
-Collaborate with R&D and product development teams to ensure that new formulations meet regulatory requirements for safety and efficacy.
-Advise on GMP (Good Manufacturing Practice) Guidelines:
Provide expert guidance on GMP requirements for our manufacturing processes.
Assist in the preparation and successful acquisition of GMP certification for our kitchen and production facilities. Ensure ongoing GMP compliance through regular audits and process improvements.
Point of Contact for Taiwan FDA Queries:
-Serve as the primary point of contact for any inquiries from the Taiwan FDA regarding product compliance and safety.
-Respond promptly to any regulatory queries and maintain a good working relationship with FDA officials.
Support Product and Customer Care Teams:
-Collaborate with the product team to provide technical expertise on product safety, regulatory requirements, and compliance issues.
-Assist the customer care team in addressing customer inquiries related to product safety, formulations, and regulatory matters as needed.
-Provide timely and accurate information to ensure customer satisfaction and trust in our products.
Stay Current with Regulatory and Industry Trends:
-Keep up-to-date with the latest trends, regulations, and changes in the cosmetics industry, particularly in relation to Taiwan and international standards.
-Advise the company on potential regulatory changes and their impact on product compliance.
Qualifications:
-Bachelor's degree in a related field (e.g., Pharmaceutical Sciences, Chemistry, or Cosmetic Science).
-Valid license or certification to validate product formulas (as required by local regulations).
-In-depth knowledge of cosmetics regulations, particularly in Taiwan, and familiarity with international regulations (e.g., EU, US FDA).
-Proven experience in managing product registrations, maintaining PIFs, and ensuring GMP compliance.
-Strong communication skills with the ability to liaise effectively with regulatory bodies, internal teams, and external stakeholders.
-Attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.
-Proficiency in Mandarin and English is preferred.
-Microbiological test certificate is nice to have.